MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, requested an normal iol and the package was confirmed of the correct power.When injected the iol and as it was unfolding physician amazed to see the usual toric iol marks on the optic.The physician explanted the iol and replaced it with another normal lens.Additional information was received stating surgical intervention required as a result of event was iol extraction and replacement and patient was not hospitalized as a result of this event.Additional information received via medwatch program stating the surgery performed was left eye cataract extraction surgery and intraocular lens (iol) implantation.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.10.The lens was returned in the opened lens carton.Part of the additional label set was returned.The lens was inside the lens case.The lens was returned in two pieces, typical when an iol is removed from the eye.Ophthalmic viscosurgical devices (ovd) was observed on the lens.The lens was cleaned with klrp.Toric axis marks were visible on the lens pieces.The power and resolution were verified by a trained technician.The lens met specifications for an 20.5 diopter lens.Photos were provided that matched the returned product.The lens was returned and the reported complaint was verified.The lens was not the indicated model/diopter per the labelling; based on results of the sample evaluation the returned lens was determined to be an 20.5 diopter lens.The most likely root cause was determined to be improper line clearance at the casing operation.As contributing factor lack of attention was identified.A lens with toric marks was cosmetically inspected and cased with a non-toric batch.The toric marks were not detected during the cosmetic inspection.Based on the investigation results/manufacturing record reviews this was determined to be a single incident.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14989019
• Report Number: 1119421-2022-01523
• Device Sequence Number: 19303009
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: 00380655093177
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 15334514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female